The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.

NCT03384511 | Completed Phase 4 DMC

• 1 other identifier: CRTOG1701
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 PET/CT scan can predict the efficacy and adverse events of apatinib in patients with malignancies. Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated obviously in various types of tumor cells and activated endothelial cells. The arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity. The 18F-ALF-NOTA-PRGD2 will highly combine with αvβ3, and thus will monitor the antiangiogenic status.In the current study, investigators propose to evaluate the feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in malignancies.

Conditions

Malignancies; Stomach Cancer; Non-small Cell Lung Cancer; Esophageal Cancer; Breast Cancer; Ovary Cancer; Cervical Cancer

Keywords

RGD PET-CT; Apatinib

Outcome Measures

Primary Outcomes (1)

• Tumor response defined by RECIST criteria

  Tumor response will be evaluated as complete response or partial response or stable disease or PD according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

  At 1 month of the study

Secondary Outcomes (3)

• Days from the start of therapy to disease progression or death due to any cause

  At 6 months of the study

• Days from the start of therapy to death due to any cause

  Up to 12 months

• Treatment-Related Adverse Events as Assessed by CTCAE

  Through study completion, an average of 6 months

Study Arms (1)

Apatinib & RGD PET/CT

EXPERIMENTAL

All of the patients will receive apatinib at oral dose of 250 mg twice daily (500 mg/day) at least 30 days.One treatment cycle is defined as 4 weeks.18F-ALF-NOTA-PRGD2 PET/CT scan will be performed berore and after one cycle of therapy. Treatment interruptions or dose reductions to 250 mg/day will be allowed for the management of adverse events. The maximum allowable period of treatment interruption is 1 week during each treatment cycle, and the dose should be re-escalated to 500 mg/day after adverse events mitigation. Treatment will not stop until disease progression, intolerable toxicity, or patients' request for withdrawal from the study.

Drug: Apatinib

Interventions

Apatinib DRUG

Patients will accept apatinib therapy and undergo baseline 18F-ALF-NOTA-PRGD2 PET/CT scans of the whole body after having met all eligibility criterias.

Also known as: YN968D1

Apatinib & RGD PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of malignancies
• Scheduled for second- or third-line apatinib therapy
• Karnofsky performance status (KPS) ≥70
• Measurable primary tumors according to Response Evaluation Criteria in Solid Tumors (RECIST)

You may not qualify if:

• Active infection, myocardial infarction within 6 months, symptoms of heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy
• The claustrophobic patients and patients with implanted metal objects
• The pregnancy
• Inability to complete the required examinations

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Unknown Facility

Jinan, Shandong, 250117, China

Location

MeSH Terms

Conditions

Neoplasms; Stomach Neoplasms; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Head and Neck Neoplasms; Esophageal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Study Officials

• Shuanghu Yuan, MD;PhD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Model Details: Apatinib at oral dose of 250 mg twice daily (500 mg/day) for a minimum of 30 days

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: December 27, 2017
• Study Start: September 30, 2016
• Primary Completion: January 28, 2018
• Study Completion: January 28, 2018
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)